COPAXONE(R) Approved by Health Canada for Patients with Clinically Isolated Syndrome (CIS) suggestive of Multiple Sclerosis (MS)



    MONTREAL, April 16 /CNW Telbec/ - Teva Neuroscience Canada announced
today that Health Canada has approved an expanded indication for COPAXONE(R)
(glatiramer acetate injection) to include the treatment of patients who have
experienced a single demyelinating event, accompanied by abnormal magnetic
resonance imaging (MRI) scans and are considered to be at risk of developing
Clinically Definite MS (CDMS), after alternative diagnoses are excluded.
COPAXONE(R) administered to patients who have experienced a single
demyelinating event has been shown to delay the onset of definite MS and
reduce the number of active brain lesions and overall disease burden
identified by MRI scans.
    COPAXONE(R) is also indicated for the treatment of ambulatory patients
with Relapsing Remitting Multiple Sclerosis (RRMS) in order to decrease the
frequency of clinical exacerbations and reduce the number and volume of active
brain lesions identified by MRI scans
    Health Canada's approval follows recent decisions by the FDA and the
European Medicines and Healthcare Products Regulatory Agency (MHRA) to expand
the label for COPAXONE(R) to include the treatment of patients with clinically
isolated syndrome (CIS) suggestive of MS.
    Up to 85% of MS patients initially experience a single neurological event
suggestive of MS, known as CIS, and it has been demonstrated that early
treatment initiation delays conversion from CIS to clinically definite MS
(CDMS). This expanded indication in Canada allows Canadian patients to begin
treatment with COPAXONE(R) from the very early stages of the disease.
    "The PreCISe trial exemplifies Teva's dedication and commitment to
further improve our understanding of MS and to provide additional benefits to
patients affected by demyelinating disorders", said Dr Jean Godin, General
Manager of Teva Neuroscience Canada. "This expanded indication for
COPAXONE(R), the leading MS disease modifying therapy both in Canada and
globally, represents another significant step towards reaching our vision to
be the North American leader in neurology through the quality of our people,
the quality of our products, and our focus on the patient."
    Health Canada granted approval after reviewing the results of the PreCISe
study, which indicated time to development of a second exacerbation was
significantly delayed in patients treated with COPAXONE(R) compared to placebo
(Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77; p=0.0005).

    About the PreCISe Study

    The multinational, multi-center, prospective, double-blind, randomized
controlled, Phase III study was conducted globally in 80 centers. It included
a total of 481 patients presenting with a single clinical episode and MRI
scans suggestive of MS over a period of up to three years. Patients included
were those who had a unifocal disease manifestation (i.e., clinical evidence
of a single lesion). Patients received either COPAXONE(R) 20mg/day or placebo
as a subcutaneous injection and continued treatment for up to three years,
unless a second exacerbation was experienced. Patients who experienced a
second exacerbation continued the trial on active treatment for an additional
two years. The primary efficacy outcome was time to development of second
exacerbation.
    A pre-planned interim analysis was performed on data accumulated from 81
percent of the three-year placebo-controlled study exposure. The PreCISe study
demonstrated that in the 25th percentile of the patient population, the number
of days to second exacerbation was more than doubled by COPAXONE(R) from 336
days to 722 days (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77)
compared with placebo.
    Moreover, there was a significant reduction in the number of new T2
lesions and in the volume of T2 lesions in the COPAXONE(R) arm compared to the
placebo arm, as measured by magnetic resonance imaging (MRI) scans following
29 months of therapy.
    COPAXONE(R) was also shown to be well tolerated in the PreCISe study,
with 84 percent of patients completing the three-year study period. The 3-year
safety and tolerability profile of COPAXONE(R) in the PreCISe study supports
the safety and tolerability seen in RRMS patients treated with COPAXONE(R).
    COPAXONE(R) is indicated for:

    
    - The treatment of ambulatory patients with Relapsing Remitting Multiple
      Sclerosis (RRMS): To decrease the frequency of clinical exacerbations
      and to reduce the number and volume of active brain lesions identified
      on Magnetic Resonance Imaging (MRI) scans.

    - The treatment of patients who have experienced a single demyelinating
      event, accompanied by abnormal MRI scans and are considered to be at
      risk of developing Clinically Definite MS (CDMS), after alternative
      diagnoses are excluded: To delay the onset of definite MS. To decrease
      the number and volume of active brain lesions and overall disease
      burden (as identified by MRI scans).
    

    For more information about COPAXONE(R), visit www.tevaneuroscience.ca for
product monograph details.

    About Teva Neuroscience

    Teva Neuroscience G.P.-S.E.N.C. is a general partnership organized under
the laws of the province of Quebec responsible for Teva Pharmaceutical
Industries Limited innovative activities in Canada. Teva Neuroscience Canada
employs 70 people, its head office is located in Montreal, Quebec.
    Teva Neuroscience continues to invest in research and development in
numerous specialty areas of unmet medical need including:

    - Multiple Sclerosis
    - Neurological neurodegenerative diseases
    - Auto-immune diseases
    - Inflammatory diseases
    - Oncology

    About Teva

    Teva Pharmaceutical Industries Ltd. (Nasdaq:   TEVA), headquartered in
Israel, is among the top 20 pharmaceutical companies in the world and is the
world's leading generic pharmaceutical company. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals and
active pharmaceutical ingredients, as well as animal health pharmaceutical
products. Over 80 percent of Teva's sales are in North America and Europe.

    Safe Harbor Statement under the U. S. Private Securities Litigation
    Reform Act of 1995:

    This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are based on
management's current beliefs and expectations and involve a number of known
and unknown risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to: our ability to successfully develop and
commercialize additional pharmaceutical products, the introduction of
competing generic equivalents, the extent to which we may obtain U.S. market
exclusivity for certain of our new generic products and regulatory changes
that may prevent us from utilizing exclusivity periods, potential liability
for sales of generic products prior to a final resolution of outstanding
patent litigation, including that relating to the generic versions of
Neurontin(R), Lotrel(R) and Protonix(R), the current economic conditions,
competition from brand-name companies that are under increased pressure to
counter generic products, or competitors that seek to delay the introduction
of generic products, the effects of competition on our innovative products,
especially Copaxone(R) sales, dependence on the effectiveness of our patents
and other protections for innovative products, the impact of consolidation of
our distributors and customers, the impact of pharmaceutical industry
regulation and pending legislation that could affect the pharmaceutical
industry, our ability to achieve expected results through our innovative R&D
efforts, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
uncertainty surrounding the legislative and regulatory pathway for the
registration and approval of biotechnology-based products, the regulatory
environment and changes in the health policies and structures of various
countries, supply interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain, our ability to
successfully identify, consummate and integrate acquisitions, including the
integration of Barr Pharmaceuticals, Inc., the potential exposure to product
liability claims to the extent not covered by insurance, our exposure to
fluctuations in currency, exchange and interest rates, significant operations
worldwide that may be adversely affected by terrorism, political or economical
instability or major hostilities, our ability to enter into patent litigation
settlements and the intensified scrutiny by the U.S. government, the
termination or expiration of governmental programs and tax benefits,
impairment of intangible assets and goodwill, environmental risks, and other
factors that are discussed in this report and in our other filings with the
U.S. Securities and Exchange Commission ("SEC").




For further information:

For further information: Joan Beauchamp, Enigma Communications, (514)
982-0308, ext. 209, 1-888-787-0308, j.beauchamp@enigma.ca

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